COMPANY: Collegium Pharmaceutical, Inc. (www.collegiumpharma.com)
JOB TITLE:Process Development Engineer I / II
LOCATION: Cumberland, RI

JOB DESCRIPTION:
Collegium Pharmaceutical, Inc., a rapidly growing specialty pharmaceutical company, is seeking a Process Development Engineer for our Dermatology and Wound Care Product Development Team. As a member of our team, you will be working with and learning from experienced pharmaceutical professionals designing, testing and executing small pilot scale manufacturing processes for Collegium’s topical wound care and dermatology products.

JOB REQUIREMENTS:

• B.S. degree or equivalent in chemical engineering, industrial pharmacy or pharmaceutics (Engineer I) or B.S. degree or equivalent with 2 – 3 years semi-solid manufacturing process development experience in the pharmaceutical, cosmetic or food industries (Engineer II).
• Proactive, innovative problem solving skills and willing to work "hands on" in the laboratory and manufacturing suite
• Highly effective interpersonal, organizational, oral and written communication skills

JOB RESPONSIBILITIES:

• Conduct design of experiment (DOE) campaigns to develop and test potential manufacturing processes for liquid, gel and other semi-solid formulations
• Assist in the writing of the Chemistry, Manufacturing and Controls sections of regulatory filings for new liquid, gel and other semi-solid drug products and medical devices
• Assist in the writing of current Good Manufacturing Practices (cGMP) compliant Master Batch Records based upon the results of process development DOE campaigns
• Work with Quality Assurance and Product Manufacturing to implement and test commercial scale cGMP compliant processes
• Oversee the transfer of manufacturing processes to contract manufacturing sites